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Lower risk Medical device recall · FDA · Published May 26, 2021

Owen Mumford Unifine Pentips Plus 4mm Needles Mixed with 8mm Needles

Owen Mumford recalls 4mm Unifine Pentips Plus needles mixed with 8mm needles. This mix-up could cause incorrect needle use during injections.

🇺🇸 FDA recall #Z-2078-2021Medical deviceOwen Mumford ›
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Recalling firmOwen Mumford USA, Inc.1755 W Oak Commons Ct · Marietta, GA 30062-2280
✎ GovInfoNow plain-language explainer

What happened, in plain English

Owen Mumford is recalling some Unifine Pentips Plus pen needles because they were accidentally mixed with 8mm needles instead of the correct 4mm size. Using the wrong needle size could lead to improper injections. Read more at govinfonow.com/recall/62482-owen-mumford-unifine-pentips-plus-4mm-needles-mixed-with-8mm.

Source Summary by GovInfoNow · govinfonow.com/recall/62482-owen-mumford-unifine-pentips-plus-4mm-needles-mixed-with-8mm · Updated August 19, 2026 · FDA enforcement record: FDA #Z-2078-2021

Cite this page

“Owen Mumford Unifine Pentips Plus 4mm Needles Mixed with 8mm Needles.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/62482-owen-mumford-unifine-pentips-plus-4mm-needles-mixed-with-8mm. Based on FDA recall #Z-2078-2021 (https://api.fda.gov/device/enforcement.json?search=recall_number:%22Z-2078-2021%22&limit=1).

Why it’s dangerous

The needles were mixed up during packaging, so some 4mm needles were included in packages labeled for 8mm needles. Using the wrong size could cause incorrect injections or injury.

Who’s affected

People who own or use Unifine Pentips Plus pen needles with lot numbers 20V4001.Z3999, 20V4001.Z4019, or 20V4001.Z411 are affected. Those who use the needles for injections are most at risk.

How to tell if you have this one

Check the lot number on the packaging: 20V4001.Z3999, 20V4001.Z4019, or 20V4001.Z411. The needles are labeled as Unifine Pentips Plus with a built-in needle remover.

  • Brand
    Owen Mumford
  • Category
    Medical device
Based on the official FDA remedy

What to do — step by step

  1. Check Needle Lot Number

    Look for lot numbers 20V4001.Z3999, 20V4001.Z4019, or 20V4001.Z411 on the packaging.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 28 states.

Alaska: nationwideAKMaine: nationwideMEVermont: named in the noticeVTNew Hampshire: named in the noticeNHWashington: named in the noticeWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: named in the noticeMNIllinois: named in the noticeILWisconsin: nationwideWIMichigan: named in the noticeMINew York: named in the noticeNYRhode Island: nationwideRIMassachusetts: named in the noticeMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: named in the noticeIAIndiana: nationwideINOhio: named in the noticeOHPennsylvania: named in the noticePANew Jersey: named in the noticeNJConnecticut: nationwideCTCalifornia: named in the noticeCAUtah: named in the noticeUTColorado: named in the noticeCONebraska: nationwideNEMissouri: named in the noticeMOKentucky: nationwideKYWest Virginia: named in the noticeWVVirginia: named in the noticeVAMaryland: nationwideMDDelaware: nationwideDEArizona: named in the noticeAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: named in the noticeTNNorth Carolina: named in the noticeNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: named in the noticeOKLouisiana: nationwideLAMississippi: named in the noticeMSAlabama: named in the noticeALGeorgia: named in the noticeGAHawaii: named in the noticeHITexas: named in the noticeTXFlorida: named in the noticeFL

FDA distribution: “US Nationwide distribution in the states of AL, AZ, CA, CO, FL, GA, HI, IA, IL, MA, MI, MN, MO, MS, NC, NH, NJ, NY, OH, OK, PA, TN, TX, UT, VA, VT, WA, and WV.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Alabama, Arizona, California, Colorado, Florida, Georgia, Hawaii, Illinois, Iowa, Massachusetts, Michigan, Minnesota, Mississippi, Missouri, New Hampshire, New Jersey, New York, North Carolina, Ohio, Oklahoma, Pennsylvania, Tennessee, Texas, Utah, Vermont, Virginia, Washington, West Virginia.

Recall timeline

FDA published this recall 56 days after the firm started it.

1. Firm started the recall: May 26, 202112. FDA classified it Class II: Jul 15, 202123. Published in FDA’s Enforcement Report: Jul 21, 202132021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #Z-2078-2021 (May 26, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for Z-2078-2021 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA